Poster Presentation Featuring Positive Topline data from Phase 1 Trial Evaluating THR-149, a novel, potent plasma kallikrein inhibitor for DME

Leuven, Belgium , 9 October 2019 – 7.30 AM CET Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing innovative treatments to preserve vision in patients with diabetic eye disease, today announces that the Company will be providing a business and clinical update at upcoming American Academy of Ophthalmology's annual meeting (AAO) and Ophthalmology Innovation Summit (OIS@AAO) in San Francisco.

Patrik De Haes, MD, CEO of Oxurion will be presenting the Company’s business and diabetic eye disease clinical pipeline at the Ophthalmology Innovation Summit (OIS) meeting which will be held on 10th October 2019, at the Hilton San Francisco Union Square.
In his presentation, Dr De Haes will focus on the prospects for Oxurion’s two VEGF-independent drug candidates, THR-149 and THR-687, which are being developed for diabetic macular edema (DME).  THR-149 has recently completed a positive Phase 1 study and Oxurion expects to announce results from an on-going Phase 1 study with THR-687, a pan-RGD integrin antagonist, towards the end of 2019.

At the American Academy of Ophthalmology's annual meeting (AAO), Arshad M Khanani, MD will present ‘A Phase 1, Open Label, Dose Escalation study of THR-149 for the Treatment of Diabetic Macular Edema (DME)’ (poster presentation – P0455).

Topline data from the Phase 1 study (n=12) evaluating THR-149 for treatment of DME show that THR-149 is well-tolerated and safe.
Study data also indicate that a single injection of THR-149 resulted in an immediate (day 1) positive impact on patient’s Best Corrected Visual Acuity (BCVA). This improvement continued with an average improvement in BCVA of up to 7.5 letters being achieved at Day 14. Importantly, this activity was also maintained with an average improvement in BCVA of 6.4 letters at the end of study (Day 90).

THR-149 has been developed with Bicycle Therapeutics (Nasdaq: BCYC). Oxurion holds the exclusive license to the PKal inhibitor portfolio originating from this partnership.

Patrik De Haes, M.D., CEO of Oxurion, said: “We are pleased to have the opportunity to present the positive findings from our successful Phase I study to the large number of retinal physicians attending both OIS and AAO. The clinical profile of THR-149 holds potential for it to become a best-in-class PKal inhibitor for the treatment of DME. We are currently preparing a Phase 2 study with multiple injections of THR-149, and we anticipate the first patient to be enrolled in early 2020.”

Oxurion will be welcoming visitors at booth #5123 in the AAO Exhibition Hall.

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For further information please contact:

Oxurion NV
Wouter Piepers,
Global Head of Investor Relations
& Corporate Communications
Tel: +32 478 33 56 32
wouter.piepers@oxurion.com

 
Citigate Dewe Rogerson
David Dible/ Sylvie Berrebi/Nathaniel Dahan
Tel: +44 20 7638 9571
oxurion@citigatedewerogerson.com

About Oxurion

Oxurion (Euronext Brussels: OXUR) is a biopharmaceutical company currently developing a competitive pipeline of three novel clinical drug candidates for diabetic eye disease, a leading cause of blindness in people of working age worldwide. The pipeline comprises:

  • THR-149, a plasma kallikrein inhibitor, that has shown positive topline Phase 1 results for the treatment of DME. The Company is currently preparing to conduct a Phase 2 clinical program, which is expected to start in H1 2020
  • THR-317, a PlGF inhibitor is being evaluated for treatment of diabetic macular edema (DME), as well as for the treatment of Idiopathic Macular Telangiectasia Type 1 (MacTel 1), a rare retinal disease that affects the macula and can lead to vision loss
  • THR-687, a pan-RGD integrin antagonist, which is in a Phase 1 clinical study assessing it as a treatment for diabetic retinopathy and DME. Topline results from this study are expected in late 2019

Oxurion is headquartered in Leuven, Belgium, and is listed on the Euronext Brussels exchange under the symbol OXUR. More information is available at www.oxurion.com.

Important information about forward-looking statements

Certain statements in this press release may be considered “forward-looking”. Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company’s Annual Report. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of Oxurion in any jurisdiction.  No securities of Oxurion may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. state securities laws.